64E-28.007. Operational Requirements for a Tattoo Establishment  


Effective on Wednesday, September 5, 2012
  • 1(1) Tattoo establishments shall have walls, a floor, and a ceiling. Floors and walls located in the tattooing area, the area where items are 25c26leaned and sterilized, and in the restrooms shall be 35c36onstru37c38ted of non-absorbent, easily 42c43leanable materials. The entire establishment shall be maintained in 52c53lean 54c55ondition and good repair.

    59(2) There shall not be a direct opening between a tattoo establishment and any building or portion of a building used as living or sleeping quarters. This shall be accomplished, at a minimum, by a solid floor to ceiling wall of separation.

    101(3) A tattoo establishment shall not be located in an area where food is prepared.

    116(4) Eating and drinking, except for the purpose of administering first aid, and smoking are prohibited in areas where tattooing is performed or where instruments and supplies are 144c145leaned and stored.

    148(5) Water supplies shall 152c153omply with the provisions of Chapter 64E-8 or 62-550, F.A.C.

    163(6) Sewage disposal shall 167c168omply with the provisions of Chapter 64E-6 or 62-200, F.A.C.

    178(7) The establishment shall use effe184c185tive measures to prote189c190t against the entran194c195e, breeding, and presen199c200e of vermin, such as insects and rodents. Openings to the outside shall be prote215c216ted by su219c220h means as self-224c225losing doors, 227c228losed windows, or s232c233reening. If s236c237reening is used, it shall not be less than sixteen (16) mesh to the inch.

    252(8) Animals shall not be allowed in a tattoo establishment, ex263c264ept as provided under Section 269413.08, F.S. 271Aquariums with fish shall be allowed in waiting rooms and non-pro282c283edural areas only.

    286(9) Ea288c289h tattoo establishment shall have an artifi296c297ial light sour300c301e equivalent to at least one hundred (100) foot 310c311andles in the tattooing area and in the area where items are 323c324leaned and sterilized.

    327(10) Restrooms shall be supplied with toilet tissue, a hand sink supplied with running water under pressure, liquid soap, a dispenser with single-use paper towels, and a waste receptacle. Signage shall be posted in the restroom to instruct employees that they must thoroughly wash their hands before returning to work.

    377(11) A handsink with unobstru382c383ted a385c386c387ess shall be located within each tattoo area or centrally located within the overall workroom area, so that each tattoo artist has access to the handsink for handwashing.

    415(a) The handsink shall be supplied with running water under pressure, liquid soap, a dispenser with single-use paper towels, and a waste receptacle.

    438(b) A restroom handsink may be used as the handsink provided that it is located within the tattoo establishment and it meets the above stated requirements.

    464(12) At a minimum, 468c469ontaminated, reusable items shall be 474c475leaned manually in a sink, separate from the handsink(s), or me486c487hani488c489ally in an ultrasoni493c 494ma495c496hine prior to sterilization.

    500(a) If items are manually 505c506leaned in a sink, the sink shall be deep enough to allow 518c519omplete submersion of the items. Gloves shall be worn when manual 530c531leaning is performed.

    534(b) If items are 538c539leaned in an ultrasoni543c 544ma545c546hine, the ma549c550hine shall be used in a556c557c558ordan559c560e with the manufa564c565turer’s instructions, whi568c569h shall be available for review by the department at the time of inspe583c584tion.

    585(586c587) After 589c590leaning, items shall be rinsed and allowed to air dry or shall be dried with single-use paper towels prior to pa611c612kaging for sterilization.

    615(d) If only individually packaged, pre-sterilized, single-use items are used in the establishment, the 629c630leaning sink and ultrasoni634c 635ma636c637hine requirements do not apply.

    642(13) A tattoo establishment shall have a steam auto651c652lave for sterilizing instruments.

    656(a) The auto659c660lave shall be used in a666c667c668ordan669c670e with the manufa674c675turer’s instru677c678tions for pa681c682kaging, loading, and pro686c687essing items.

    689(b) The auto692c693lave shall be maintained to ensure proper operation.

    7011. The auto704c705lave shall be 708c709leaned at the frequen713c714y re716c717ommended by the manufa721c722turer and shall be servi727c728ed at least once a year or at the frequen738c739y re741c742ommended by the manufacturer.

    7462. A 748c749opy of the manufa753c754turer’s instru756c757tions for operating, 760c761leaning, and servi764c765ing the auto768c769lave shall be maintained in the tattoo establishment and shall be available for review by the department at the time of an inspe792c793tion.

    794(14) When using an autoclave, sterilization shall be verified through:

    804(a) A 806c807hemi808c809al indi811c812ator strip pla815c816ed inside one packet in ea822c823h load to monitor the sterilization pro830c831edure. The strip must indi836c837ate exposure to steam and the auto844c845lave operating temperature.

    848(b) Testing with spore strips at a minimum frequen857c858y of every 40 hours of operation of the auto868c869lave, but not less than on a quarterly basis.

    8781. Test results shall be 883c884onfirmed by an independent laboratory.

    8892. In the event of positive results, the auto898c899lave shall be immediately taken out of servi907c908e and all unused items pro914c915essed in the auto919c920lave sin922c923e the most re927c928ent negative test results shall be 934c935onsidered non-sterile.

    9373. While the auto941c942lave remains out of servi947c948e, tattooing may 951c952ontinue provided either another properly fun958c959tioning auto961c962lave is pla965c966ed in servi969c970e in the establishment or all single-use, pre-sterilized instruments are used.

    9814. When the improperly fun986c987tioning auto989c990lave has been restored to proper fun997c998tion, whi1000c1001h shall be 1004c1005onfirmed by follow-up testing, it may be pla1013c1014ed ba1016c1017k in servi1020c1021e.

    1022(15) Ea1024c1025h tattoo establishment shall maintain auto1031c1032lave sterilization re1035c1036ords onsite. The re1040c1041ords shall, at a minimum, in1047c1048lude the following information:

    1052(a) Auto1054c1055lave log showing 1058c1059umulative run time, quantity and types of items sterilized on a given date, and the date spore strip testing was 1079c1080ondu1081c1082ted.

    1083(b) Spore strip results provided by an independent laboratory.

    1092(16) If only individually packaged, pre-sterilized, single-use items are used, an auto1104c1105lave shall not be required nor the requirements specified in subparagraphs 12., 13., 14., and 15. of this section.

    1124(a) Individually packaged, pre-sterilized, single-use items shall be sterilized with ethylene gas or gamma rays and shall be labeled with the expiration date by the manufacturer.

    1150(b) If a pa1154c1155kage 1156c1157ontaining pre-sterilized, single-use items has been 1163c1164ompromised, the 1166c1167ontents shall be dis1171c1172arded.

    1173(17) Pa1175c1176kages of sterile items, which are sterilized by the tattoo establishment, shall be labeled with the date of autoclaving. If any pa1198c1199kage has been 1202c1203ompromised, the items shall be re-sterilized.

    1209(18) All packages of sterile items shall be stored in a clean, dry, covered container or in a clean, dry cabinet until just prior to use.

    1235(19) Work 1237c1238hairs, tables, stands, 1241c1242abinets, and 1244c1245ounter tops shall have a smooth, non-porous, easily 1253c1254leanable surfa1256c1257e, and shall be cleaned and disinfected after ea1266c1267h customer.

    1269(20) If any liquid produ1274c1275t is not in its original 1281c1282ontainer, the 1284c1285ontainer into whi1288c1289h the produ1292c1293t has been pla1297c1298ed shall be labeled with the name of the produ1308c1309t.

    1310(21) Each tattoo establishment shall maintain the following records:

    1319(a) Customer records, including parental consent;

    1325(b) Auto1327c1328lave sterilization records and maintenance records;

    1334(c) Do1336c1337umentation identifying the method of sterilization utilized by the manufa1347c1348turer if the information is not printed on the pa1358c1359kaging of the item.

    1363(d) The re1366c1367ords stated in paragraphs (a), (b), and (c) above shall be maintained for two years with those records for the current licensing period maintained onsite in the establishment and available for review by the department at the time of inspection.

    1407(e) Personnel records of each tattoo artist who works in the establishment. The re1421c1422ord shall 1424c1425ontain the tattoo artist’s name, address, date of birth, and the li1437c1438ense number issued by the department. Personnel re1446c1447ords shall be maintained for at least 2 years after an artist’s employment ends.

    1461(22) A tattoo establishment shall allow the department to 1470c1471ondu1472c1473t, at minimum, annual inspe1478c1479tions for the purpose of ensuring compliance with Sections 381.00771-.00791, F.S., and these rules. Results of each inspection shall be recorded on DH Form 4153, 7/12, Tattoo Establishment Inspection Report, herein incorporated by reference and which can be obtained at 1519https://www.flrules.org/Gateway/reference.asp?No=Ref-01527 1521or from the environmental health section of the county health department having jurisdiction.

    1534(23) Biomedi1536c1537al waste shall be managed in a1544c1545c1546ordan1547c1548e with Section 1551381.0098, F.S. 1553and Chapter 64E-16, F.A.C. Regular solid waste shall be 1562c1563olle1564c1565ted, stored and disposed of in a manner and at a frequen1577c1578y that does not 1582c1583reate a sanitary nuisan1587c1588e, as defined in Chapter 386, F.S.

    1595(24) Tattoo establishments, currently operating on the effective date of this rule, which are not in full 1612c1613omplian1614c1615e with the handsink and cleaning sink requirements shall have six months from the effective date of this rule to 1635c1636omply with the requirements.

    1640Rulemaking Authority 1642381.00789 FS. 1644Law Implemented 1646381.00779 FS. 1648History–New 9-5-12.

     

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